Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic … (NCT06823258) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function
32 participantsStarted 2025-02-28
Plain-language summary
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;
✓. The subjects agree to have no plans to conceive or donate sperm/eggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);
✓. On the day of signing the informed consent form, both males and females must be at least 18 years old;
✓. The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-33 kg/m2 (including both ends);
✓. Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min.
✓. BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;
✓. Age matching with the matched hepatic impairment group, with a mean of ± 5 years;
✓. Gender matching with the matched hepatic impairment group，with the same number of individuals for each gender;
Exclusion criteria
✕. During the screening period, 12 lead electrocardiogram results showed QT interval prolongation (male QTcF\>470 ms; female QTcF\>480 ms);
✕
What they're measuring
1
Peak plasma concentration (Cmax) of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
2
Pharmacokinetic parameters AUC0-t of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
3
Pharmacokinetic parameters AUC0-∞ of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
. Individuals at increased risk of QT interval prolongation (such as heart failure, congenital long QT syndrome, family history of long QT syndrome, refractory hypokalemia, or unexplained sudden death in immediate family members under 40 years old);
✕. Individuals who have previously suffered from cardiovascular diseases (such as organic heart disease, myocardial infarction, angina pectoris, arrhythmia, etc.) and are deemed unsuitable for inclusion by the researchers;
✕. Severe or poorly controlled hypertension, including a history of hypertensive crisis or hypertensive encephalopathy; Within 2 weeks prior to the first administration, adjustments were made to antihypertensive medication due to poor blood pressure control; During the screening period, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg;
✕. Those who have difficulty swallowing or have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion, and are deemed unsuitable for inclusion by the researchers;
✕. Individuals who are prone to allergic reactions or have an allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the study drug or any component of the study drug;
✕. Individuals who have participated in any other clinical trials within the previous 3 months and have used study drugs or plan to participate in other clinical trials during the study period (those who have not been given the study drug or placebo after enrollment may be included);
✕. Individuals who have donated blood or lost blood ≥ 400 mL within the first 3 months of screening, or have received blood transfusions or used blood products, or intend to donate blood during the trial period or within 1 month after the trial ends;